Patients With Crohn's Disease and Permanent Ileostomy Are Universally Excluded From Clinical Trials: A Systematic Review

Author:

Vuyyuru Sudheer K.1,Rieder Florian23,Solitano Virginia1,Nguyen Tran M.4,Crowley Eileen5,Narula Neeraj6,Singh Siddharth7,Ma Christopher89,Jairath Vipul1410

Affiliation:

1. Division of Gastroenterology, Department of Medicine, Schulich School of Medicine, Western University, London, Ontario, Canada;

2. Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA;

3. Department of Gastroenterology, Hepatology and Nutrition, Digestive Diseases and Surgery Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA;

4. Lawson Health Research Institute, Western University, London, Ontario, Canada;

5. Division of Pediatric Gastroenterology, Department of Pediatrics, Children's Hospital Western Ontario, London Health Sciences Centre, Western University, London, Ontario, Canada;

6. Department of Medicine, Division of Gastroenterology, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada;

7. Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla, California, USA;

8. Departments of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada;

9. Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada;

10. Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.

Abstract

INTRODUCTION: We performed a systematic review to investigate whether patients with Crohn's disease (CD) and permanent ileostomy (PI) have been included in clinical trials evaluating biologics and small molecules. METHODS: MEDLINE, Embase and Cochrane library (CENTRAL) data bases were searched from inception to May 16, 2022 for placebo controlled induction and/or maintenance randomized controlled trials assessing biologics and oral small molecules in adult patients with active CD. RESULTS: Of the 81 induction and maintenance trials assessing biologics and oral small molecules in CD, none permitted the enrollment of patients with PI. Patients with CD and PI have been universally excluded from pharmaceutical trials of biologics and small molecules to date. DISCUSSION: There is an urgent need to identify barriers to enrollment and develop eligibility and outcome measures enabling the inclusion of patients with CD and PI into clinical trials.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Gastroenterology,Hepatology

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